An interventional study of Human urinary kininogenase(HUK) and Placebo in Acute Ischemic Stroke, sponsored by First Affiliated Hospital of Harbin Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by First Affiliated Hospital of Harbin Medical University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. It will also learn about the correlation between inflammatory factors and AIS prognosis, in order to clarify the efficacy and safety of Urinary Kallidinogen in the acute phase of AIS.
The study process lasts for a total of 90 days, including the screening period, treatment period, and follow-up period. During the treatment period, the experimental group is treated with HUK in the 48 hours of AIS plus routine clinical treatment, while the control group receives routine clinical treatment group for 7 days.All patients are followed up until the 90th day after stroke. The sample size of the study is 200 patients. The ratio of the experimental group to the control group was 1:1.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →First Affiliated Hospital of Harbin Medical University is the lead sponsor of 73 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will be given urinary kallidinogenase for injection，0.15 peptide nucleic acids (PNA)， once a day for 7days plus routine clinical treatment
Drug: Human urinary kininogenase(HUK)
Normal sodium chloride injection plus routine clinical treatment
Other: Placebo
Experimental group (HUK plus routine clinical treatment): administered within 48 hours of AIS onset, 0.15PNA unit was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day.
Also known as: Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065
Placebo group (Normal sodium chloride injection plus routine clinical treatment): Normal sodium chloride administered within 48 hours of AIS onset, by intravenous infusion for not less than 50 minutes, once a day.
Also known as: Normal sodium chloride injection
The Favorable Stroke Outcome of 90 days
mRS 0-2
Time frame: 90 days after treatment
The changes of the serum inflammatory markers before and after treatment
Complete Blood Count、CRP、IL-6、HCY、NSE
Time frame: Baseline、1 day after treatment、3 days after treatment、90 days after treatment
The changes of NIHSS before and after treatment
National Institute of Health stroke scale, NIHSS
Time frame: Baseline、7 days after treatment
Stroke recurrence rate
Ischemic stroke
Time frame: 90 days after treatment
The incidence of intracranial hemorrhage
Symptomatic intracranial hemorrhage
Time frame: 90 days after treatment
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First Affiliated Hospital of Harbin Medical University